Integration of Wearable Derived Stress and Sleep Metrics and Stool Characteristics to Characterize Psychosomatic Health A Prospective Observational Cohort

This is a prospective, single-arm, observational cohort study aiming to objectively characterize the complex relationship between physiological stress, sleep, and gut function in adults with Irritable Bowel Syndrome (IBS) or irregular stool patterns.

• Problem: Functional gut disorders like IBS affect over 700 million people, and current diagnosis and management often rely on subjective patient-reported outcomes. The gut-brain-microbiome axis is central to these psychosomatic disorders.
• Need: Objective, non-invasive, continuous monitoring tools are needed to understand the temporal link between physiological states (stress/sleep) and gut function.
• Solution: Integrate consumer-grade wearable data (Heart Rate Variability - HRV, sleep) with AI-powered toilet sensor data (stool form, defecation effort) and serial stool microbiome analysis.
• Goal: Generate clinical evidence for stress-linked motility patterns, predict IBS flare-ups, and help differentiate IBS from Inflammatory Bowel Disease (IBD).

Study Design and Methodology

• Participants: 50 adults (40 with Rome IV-confirmed IBS, 10 without IBS) aged 18-65, recruited from gastroenterology clinics and digital campaigns in India.
• Exclusions: Active, uncontrolled IBD or use of medications significantly altering gut motility/autonomic function (unless stable for >3 months).
• Duration: 4 weeks (28 days) of continuous monitoring.
• Technology
• Nitto SELF Wearable: Wrist-worn device for streaming HR, HRV, and sleep metrics.
• MicroHeal Stool Tracking Device: Toilet-mounted device for capturing stool data and defecation effort.
• Custom Mobile App: For daily logging of the Bristol Stool Form Scale (BSFS) and self-reported mental health scales (DASS-21, PHQ-9, GAD-7).